We respect patients
Biogen is a global biopharmaceutical company focused on discovering, developing, manufacturing and delivering therapies to patients for the treatment of neurological diseases, autoimmune disorders and rare diseases.
We treat patients with respect. We work to understand and meet their needs. We tell the truth about our products and capabilities, and we do not make promises we can’t keep. In short, we strive to treat patients as they want to be treated.
MAKE SURE YOU
- Only interact with patients in circumstances permitted by company policy and local rules and regulations
- Interact with each patient fairly and honestly
- Are responsive to patient and customer requests and questions
- Promise only what you can deliver and deliver on what you promise
- Respect the physician-patient relationship
- Respect the privacy of patients' healthcare information
WATCH OUT FOR
- Pressures from colleagues or supervisors to cut corners on safety, quality or standards
- Temptations to tell others what you think they want to hear rather than the truth
- Giving medical advice inadvertently or overtly
Interactions with Patients and Patient Advocacy Organizations
As part of Biogen’s commitment to supporting optimal patient care and sustainable health care systems globally, we recognize the importance of fully understanding the needs of the patient communities we serve. In our interactions with patient advocacy groups and allied organizations, we strive to build relationships based on mutual respect and transparency. Ensuring independence of these groups’ patient voice, being transparent in our interactions and working cooperatively for the benefit of patients are at the core of these standards.
MAKE SURE YOU
- Ensure that all our product communications made with patient organizations are educational, accurate and consistent with applicable company policies and with legal and regulatory standards
- Structure any interaction to ensure the independence of any patient organizations
- Have in place written documentation setting out the nature and purpose of any support
- Do not require that we are the sole funder of the patient organization or any of its programs
WATCH OUT FOR
- Requests to be the sole funder of the organization
- Unclear expectations and ambiguity around the nature or purpose of the involvement
- Any request for lack of transparency
Protecting Patient Privacy
Patient information is considered sensitive information and is protected by regional, national, federal and state privacy laws and regulations in all Biogen markets and must be secured and kept confidential. Original copies of medical records should never leave our facilities unless authorized by the Legal Department. A patient, or the patient’s legally authorized representative, may request a copy of his or her own medical records from healthcare providers.
Questions & Answers
I’m concerned that the company may have medical information about me that I wouldn’t want others to have access to. Is my medical information secure and protected?
Yes. All medical and health-related information about employees, such as information from our group health plan, is considered strictly confidential and subject to privacy safeguards.
Removing Barriers to Care
Our Patient Services teams help improve patients’ lives every day. They focus on supporting patients through product education programs, providing services that facilitate access to our treatments, and ensuring safety and compliance with relevant regulatory standards.
Patient Services team members support patients in navigating a complex healthcare market place. This can include finding resources to assist patients and providing information to private companies so that claims can be handled expeditiously.
Product Quality and Safety
Biogen trusts and empowers its employees to uphold quality as an integral part of their responsibilities in developing, manufacturing new and existing therapies. Quality is part of our culture and is integrated into all critical business and decision-making processes. All individuals involved in the development and manufacture, and distribution of our medicines are accountable for the quality of our products. These expectations are supported through investment in comprehensive training, improvement of processes, world-class production facilities, continuous assessment, and robust employee development programs.
The quality of our products and therapies and the safety and well-being of patients is Biogen’s top priority. As such, we maintain a demonstrable commitment to the quality, efficacy, and safety of our products in compliance with all applicable global requirements regulating their development, manufacture and distribution.
Biogen monitors the quality and safety of its products through the diligent collection of information about user experiences. Unfavorable results or adverse events involving our products must be reported to regulatory authorities appropriately. Biogen is obligated to report safety information related to any of its products.
Biogen’s policy is to comply with all regulations and laws worldwide relating to adverse event reporting.
Therefore, all adverse events must be reported to Biogen Safety and Benefit-Risk Management (SABR) or to a local Biogen safety department. All employees are responsible for reporting AEs to SABR or to their local safety department within one (1) business day of learning of the AE. In addition, all company-sponsored websites with free text fields must be monitored for adverse events.
An adverse event (AE) is any untoward (unfavorable) or adverse medical occurrence in a patient or clinical investigation subject who is administered a medicinal product regardless of whether there is a causal relationship with the treatment or product.
An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, regardless of whether considered related to, or caused by, the medicinal product.
Regardless of whether the AE is thought to be caused or not caused by a Biogen product – all AEs must be reported to SABR or the local Biogen safety office.
The following are examples of adverse events:
- “Patient had a headache”
- “Patient experienced an infusion reaction”
- “Patient was involved in a car accident”
In addition to AEs, safety information required to be collected and reported to the safety department includes:
- AEs associated with Product Complaints (PCs) such as “the taste of a tablet caused a patient to feel nauseous”
- Exposure during pregnancy or breastfeeding, including paternal exposure
- Overdose, misuse, abuse, medication error, off-label use (use of medicines outside the terms of the license)
- Lack of efficacy
- Occupational exposure
- Suspected transmission of an infectious agent (contamination)
- Drug interactions
MAKE SURE YOU
- Are always open to suggestions and comments from customers and others about possible product improvements
- Speak up if you have concerns about any problem or issue in product quality or our customer service
- Report adverse events or product quality problems you hear of within one business day even if you are not sure there is a cause and effect relationship between the product and the “event”
- For employees who engage vendors that are reasonably expected to receive or handle adverse event information (this includes but is not limited to vendors contracted for Organized Data Collection Programs such as Patient Support Programs, Market Research, and Social media activities) must Notify SABR or their local safety department of the program prior to start, according to local training instructions. These vendors must have language in their contract describing their AE reporting requirements and must be trained on AE reporting requirements prior to interaction with patients, caregivers, or health care professionals on behalf of Biogen
- Comply with all applicable procedures designed to promote product safety, efficacy and quality, such as Good Laboratory, Good Clinical, Good Pharmacovigilance, Good Distribution and Good Manufacturing Practices
Clinical Research and Bioethics
We are proud of our work to advance human health care through the clinical research we conduct. To ensure that we abide by all laws and regulations, and our own high ethical standards, we follow all review and approval procedures before initiating research. We will protect patient safety through appropriate informed consent procedures and good clinical practices, and we will document our compliance with all applicable privacy-related policies and regulations.
We are committed to the safe and ethical use of biotechnology to improve the quality of human life, and we recognize that we must approach technology with a balance of vigilance, diligence and humility. Our approach to bioethics is guided by the Biotechnology Industry Organization’s (BIO) principles, including a respect for the potential significant benefits of biotechnology and a commitment to use it only for the benefit of humankind.
The following principles must guide us anywhere we do clinical research:
- Participants must not be exposed to unnecessary risks
- Participants must understand the nature and purpose of the research via informed consent procedures
- Privacy and confidentiality rules must be applied
- Information gathered must enable transparent and accurate reporting, interpretation and verification
MAKE SURE YOU
- Conduct clinical research in a manner that is respectful and protects the safety and autonomy of research participants
We have to do what’s right for patients. Being accurate and complete with our data is right for patients.
To learn more
- Discuss any questions or concerns about our clinical research with Regulatory Affairs, R&D Compliance, your manager, Compliance, Legal, Human Resources partners or the Helpline
- Global Clinical Trial Registration and Results Disclosure Policy
- Global Clinical Trial Transparency Policy
For all policies refer to Synapse